Whitepaper: Data Integrity: Technical controls that demonstrate trust
An increased focus on data integrity by international regulatory agencies has led to serious consequences for several companies. It has also resulted in data integrity becoming one of the top reported global issues that regulated companies face. Data governance is an integral part of a regulated company’s quality system, of which, data integrity is fundamental. As such, manufacturers and analytical laboratories are required to design and operate a system which provides an acceptable state of control based on data criticality and inherent risk.
A chromatography data system (CDS) that provides the functionality to achieve compliance is a vital partner in data integrity. Having a CDS that has been implemented appropriately and is managed correctly, with all of the necessary preventative and detection technical controls, built-in to one package that are easy to use, demonstrates a level of trust.